(29 days)
Contour® Emboli PVA, Embosphere Microspheres, EmboGold Microspehers
Not Found
No
The summary describes a physical embolic device and does not mention any software, image processing, or AI/ML terms.
Yes
The device is indicated for the embolization of hypervascular tumors and arteriovenous malformations, which is a therapeutic intervention.
No
The device is described as embolic particles used for the embolization of hypervascular tumors and arteriovenous malformations, which is a therapeutic rather than diagnostic function.
No
The device description clearly states that the device is comprised of "spherical embolic particles" provided in a "sterilized glass vial," indicating a physical, hardware-based medical device.
Based on the provided information, the Contour SE™ Microspheres are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Contour SE™ Microspheres Function: The description clearly states that these microspheres are used for the embolization of hypervascular tumors and arteriovenous malformations. Embolization is a procedure performed within the body to block blood vessels.
- Lack of Specimen Examination: There is no mention of collecting or examining specimens from the body for diagnostic purposes. The device is directly used in a therapeutic procedure.
Therefore, the Contour SE™ Microspheres are a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Contour SE TM Microspheres are spherical embolic particles and are available in a variety of particle sizes and are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. These particles are provided in a sterilized glass vial.
Contour SETM Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The Contour SE TM Microspheres are spherical embolic particles and are available in a variety of particle sizes and are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. These particles are provided in a sterilized glass vial.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Contour SE™ Microspheres have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use.
The Contour SE™ Microspheres have been tested and compared to the Summary of predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Contour® Emboli PVA, Embosphere Microspheres, EmboGold Microspehers
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
Image /page/0/Picture/0 description: The image shows the date "SEP 16 2003" in a bold, sans-serif font. The letters and numbers are evenly spaced and aligned horizontally. The text appears to be printed or stamped onto a surface.
Contour SET™ Microspheres – Sub S00 Siles
Contour SET™ Microspheres – Sub S00 Sizes
August 14, 2003
510(k) Summary K032542
| General
| Provisions | Trade Name: Contour SETM Microspheres | ||
|---|---|---|---|
| Classification Name: Artificial Embolization Device | |||
| Device | |||
| Description/ | |||
| Indications for | |||
| Use | The Contour SE TM Microspheres are spherical embolic particles and are | ||
| available in a variety of particle sizes and are indicated for use for the | |||
| embolization of hypervascular tumors and arteriovenous malformations. | |||
| These particles are provided in a sterilized glass vial. | |||
| Data Summary | |||
| Prepared | September 15, 2003 | ||
| Contact Name/ | |||
| Number | Jodi Lynn Greenizen | ||
| Regulatory Affairs Project Manager | |||
| Boston Scientific Corporation | |||
| 10 Glens Falls Technical Park | |||
| Glens Falls, NY 12801 | |||
| Name of | |||
| Predicate | |||
| Devices | Contour® Emboli PVA | ||
| Embosphere Microspheres | |||
| EmboGold Microspehers | |||
| Classification | Class III, 21 CFR 882.5950 | ||
| Submitted Per 21 CFR 807 | |||
| Performance | |||
| Standards | Performance Standards have not been established by FDA under Section 514 | ||
| of the Food, Drug and Cosmetic Act | |||
| Intended Use | |||
| and Device | |||
| Description | Contour SETM Microspheres are indicated for use for the embolization of | ||
| hypervascular tumors and arteriovenous malformations. |
.
1/2
1
2/2/ 1032542
Special 510(k) Contour SE™ Microspheres - Sub 500 Sizes August 14, 2003
| Biocompatibility | The Contour SE™ Microspheres have been tested for biocompatibility per
ISO 10993. All data demonstrate this device is biocompatible for its intended
use. |
| ------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
The Contour SE™ Microspheres have been tested and compared to the Summary of predicate device. All data gathered demonstrate this device as substantially Substantial Equivalence equivalent. No new issues of safety or efficacy have been raised.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2003
Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation 10 Glens Falls Technical Park Dix Avenue Glens Falls, New York 12885-3864
Re: K032542
Trade/Device Name: Contour SETM Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: August 14, 2003 Received: August 18, 2003
Dear: Ms. Greenizen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms. Jodi Lynn Greenizen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
.
・・・・
| 510(k) Number (if known) | -Unknown |
|---|---|
| Device Name: | Contour SE™ Microspheres |
| Indications for Use | Contour SE™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| Boston Scientific Corporation | 510(k) Number | K032542 |
|---|---|---|
| ------------------------------- | --------------- | --------------------------------------------------------------------------------------------- |
000066